Guidant Press Releases

Indianapolis, IN - Guidant Corporation (NYSE and PSX: GDT), a worldwide leader in cardiac rhythm management systems, today announced the start of a clinical study to evaluate the use of a new implantable device system designed specifically for the treatment of patients with congestive heart failure (CHF), a cardiovascular disorder affecting a large and growing patient population, who are also at significant risk for sudden cardiac death. The first patient enrolled in the study received the new CONTAK(tm) CD Congestive Heart Failure Device (CHFD) / EASYTRAK(tm) lead system, which provides pacing stimulation for both sides of the heart, along with cardioversion and defibrillation therapies.

Manufactured by Guidant''s Cardiac Rhythm Management (CRM) Group, the CONTAK CD/ EASYTRAK system is designed to stimulate both of the lower chambers of the heart in a way that enhances the heart''s pumping efficiency. Conventional systems provide pacing to stimulate only the right side of the heart and rely on the heart''s normal conduction system to transfer that pulse to the left side of the heart. The patented EASYTRAK lead system, designed in conjunction with Guidant''s Vascular Intervention Group, allows easy, convenient transvenous placement, using an over-the-wire system similar to that used in angioplasty procedures.

"We believe that this new medical device solution will provide clinical benefits in the treatment of patients at risk for sudden cardiac death and who also suffer from congestive heart failure," noted Jay Graf, president of CRM. "Effective treatment of congestive heart failure is an enormous unmet clinical need. Further, a significant portion of the federal health care budget is spent on this syndrome. To the extent our trial confirms the clinical benefit we anticipate, many patients will live more comfortable lives and spend far less time in hospitals."

The device system implanted included these components: the CONTAK CD pulse generator, which provides biventricular pacing and cardioversion/defibrillation therapies; the EASYTRAK lead, a new transvenous over-the-wire lead system developed for implantation in the coronary venous system to reach the left side of the heart; and the ENDOTAK® lead system to deliver pacing and defibrillation therapies in the right side of the heart.

The first patient in the Guidant study was implanted Wednesday, February 24 by Michael Giudici, M.D., of Genesis Medical Center in Davenport, Iowa. The patient was a 44-year-old male with nonischemic dilated cardiomyopathy and an ejection fraction (a measure of the heart''s efficiency in pumping blood) of 15 percent.

Congestive heart failure affects well over three million people in the United States alone, and 400,000 new cases are diagnosed every year, making it the most rapidly growing cardiovascular disorder. Congestive heart failure is a medical condition in which the heart is unable to pump enough blood to meet the metabolic needs of the body.

CHF is characterized by physical symptoms such as shortness of breath, problems with physical strength and stamina, fatigue, fluid retention and exercise intolerance. Patients often report disruption of their lives and dissatisfaction with their abilities to perform daily activities.

Sudden cardiac death occurs when the heart''s rhythm becomes extremely fast, limiting or eliminating effective blood flow. Death can occur within minutes. Guidant has a long history of providing the VENTAK series of implantable cardioverter defibrillators to treat sudden cardiac death. The new CONTAK CD system incorporates the technologies, therapies and ease-of-use characteristics of these devices.

A global leader in the medical device industry, Guidant Corporation provides innovative, minimally invasive and cost-effective products and services for the treatment of cardiovascular and vascular disease. For more information on Guidant''s products and services, visit the company''s web site at http://www.guidant.com.